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Quality (LIMS-QC-QA) and Production PAT/MES System





Based on research of the TOP 14 pharmaceutical companies in the world, Netorus™ system has been developed in accordance with cGMP CSV (Computer System Validation) criteria: 21 CFR PART 210, 21 CFR PART 211, 21 CFR PART 11, Q7, Q8, Q9, Q10, GAMP. Netorus™ system is a whole flow parametric release control system, a complete integration of the QC/LIMS, MES, Warehouse, Sales/ Purchase. The Netorus™ system covers 70-80 % of 21 CFR Parts 210, 211 and Q7. The remaining 20-30% refers to clinical trials, registration, buildings and facilities, management of the factory. Based on 21 CFR PART 11, the Netorus™ system can be completely validated. Typically legacy LIMS systems are limited to save data or charts from detecting instruments and input Test Reports manually. The Netorus™ system integrates LIMS with MRP and Production. It automatically acquires data from laboratory instruments and generates Test Records and Reports. You can also use barcodes for lab materials and link together with the warehouse and production to create an organic network. It includes a whole QA/QC process workflow. Most companies’ process analysis and parametric release is based on single equipment. By setting up the Netorus™ PAT, we ensure quality control of every stage of the production process, including pre-release inspections of raw materials and packaging materials, production process control, quality test, intermediate inspection, finished production inspections, until the final product audit and release. You can have real-time control of all production process, parameter analysis and release.

Netorus™ Open Architecture Structure

  • Can develop different interfaces to communicate with different software, hardware, production equipment, laboratory instruments etc.
  • Can automatically generate the whole electronic batch quality records and production records from many different existing software programs, systems, and hardware according to the pre-configured templates of electronic batch production records.
  • Netorus™ Detail GMP Risk Analysis Capability

    • Includes every detail item of all cGMP regulation documents, like 21 CFR Part 210, 211, Q7, Q8, Q9, Q10, GAMP and 21 CFR Part 11.
    • Netorus™ software can comply with all cGMP regulations, not just electronic signature and electronic records compliance.
    • FDA inspected and completely approved to detail the whole flow of electronic batch production and quality records and corresponding cGMP validation documentation.

    Netorus™ Artificial Intelligence Capability

    Client-configuration methodology allows clients to configure:
    • Test specifications
    • Test items
    • Test processes
    • Test methods
    • Test results calculation and formulation
    • Artificial intelligence test records and test report
    • Generated batch quality records
    • Generated batch production records

    Netorus™ Artificial Intelligence Manufacturing Execution System

    • Can self-configure different process steps and process parameters/range(s) for different products
    • Clients can use Netorus™ MES software to control the equipments' PLC to implement data acquisition and process control.